Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation

Peking University

Status: Unknown

Conditions: Arthroplasty, Replacement, Knee; Knee Osteoarthritis

Treatments: Device: Smart Kneebrace with a smart phone app; Other: regular rehabilitation procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT03365284

PUPHACRCE

Details and patient eligibility

About

This study aims to investigate the effect of Smart Kneebrace use for osteoarthritis patients after total knee arhtroplasty (TKA) on post-operative performance.

Full description

This is a single-center, open-label randomized controlled clinical trail. A total of 60 participants will receive total knee arthroplasty, who will be randomly assigned into experiment or control group. Smart Kneebrace will be used for the patients during the rehabilitation for the patients in experiment group, while the patients in the control group will not receive such a smart kneebrace. Postoperative joint angles as well as visual analog scale pain score, the Western Ontario and McMaster Universities Osteoarthritis Index knee society score will be estimated before operation and at 6/12 weeks after operation.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ready to receive single-side TKA

Exclusion criteria

• contraindication of surgery
• self-reported diseases that cause lower limb disability (for example, cerebrovascular disease especially stroke)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Smart Kneebrace

Experimental group

Description:

Smart Kneebrace with a smart phone app will be used during the rehabilitation after surgery for three months

Treatment:

Device: Smart Kneebrace with a smart phone app

without Smart Kneebrace

Placebo Comparator group

Description:

regular rehabilitation procedure will be applied after surgery

Treatment:

Other: regular rehabilitation procedure